A Study of Glucagon Administered in Different Forms and Routes to Healthy Adults

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2011-11-30

Brief Summary

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The main purpose of this study was to evaluate the safety and tolerability of nasal glucagon (NG). The study drug was delivered into the participant's nostril (intranasally) or was given as an injection just under the skin (subcutaneously) once in each of four study periods. The study lasted about 23 days for each participant.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Nasal Glucagon (NG) - 0.5 mg

Ng dose at 0.5 milligram (mg) administered once in one of four study periods.

Group Type EXPERIMENTAL

Nasal Glucagon

Intervention Type DRUG

Administered intranasally.

NG - 1.0 mg

Ng dose at 1.0 milligram (mg) administered once in one of four study periods.

Group Type EXPERIMENTAL

Nasal Glucagon

Intervention Type DRUG

Administered intranasally.

NG - 2.0 mg

Ng dose at 2.0 milligram (mg) administered once in one of four study periods.

Group Type EXPERIMENTAL

Nasal Glucagon

Intervention Type DRUG

Administered intranasally.

SC Glucagon 1 mg

Subcutaneous (SC) glucagon dose of 1 mg, in one of four study periods.

Group Type ACTIVE_COMPARATOR

Glucagon

Intervention Type DRUG

Administered SC.

Interventions

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Nasal Glucagon

Administered intranasally.

Intervention Type DRUG

Glucagon

Administered SC.

Intervention Type DRUG

Other Intervention Names

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AMG 504-1 LY900018

Eligibility Criteria

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Inclusion Criteria

* Body mass index (BMI) greater than or equal to 20.00 and below or equal to 28.00 kg/m².
* Light-, non- or ex-smokers.
* Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations (hematology, biochemistry, ECG and urinalysis).

Exclusion Criteria

* Presence of any nose piercings.
* History of significant hypersensitivity to glucagon or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs.
* Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
* Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease.
* Presence of clinically significant findings on nasal examination and bilateral anterior rhinoscopy.
* Fasting blood glucose above 5.0 millimoles per liter (mmol/L) at screening, following a 12-hour fasting period.
* Fasting blood glucose assessed with a glucose meter above 5.5 mmol/L 0.5 hour before each dosing.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes